Class Class I

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034)

K244034 2025-02-06 Special
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Description

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine by Ever Global (Vietnam) Enterprise Corporation, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK244034
Clearance Date2025-02-06
Clearance TypeSpecial
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K244034

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034) cites 1 predicate device and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K193555Disposable Powder Free Nitrile Examination Glove, Blue Colo...Ever Global (Vietnam) Enterprise Corp2020

Later devices that cite this one as their predicate

Devices that cite K244034
K numberDeviceApplicantYear
K252244Disposable Powder Free Nitrile Examination Glove, Blue Colo...Ever Global (Vietnam) Enterprise Co...2025
K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and t...Basic Medical Technology, Inc.2025

Trace the full predicate network for K244034

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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